Sporanox (itraconazole) capsules — Blue Cross Blue Shield of New Mexico

Preferred products

• itraconazole capsules (generic)

Initial criteria

• ONE of the following:
• A. The patient has a diagnosis of onychomycosis (tinea unguium) AND ALL of the following:
• 1. The requested agent is Sporanox (itraconazole) capsules AND
• 2. The patient has not received treatment for onychomycosis with the requested agent within the past 12 months AND
• 3. The patient has ONE of the following: diabetes mellitus, peripheral vascular insufficiency, immune deficiency due to medical condition or treatment (e.g., cancer chemotherapy, HIV/AIDS, anti-rejection therapy post organ transplant) AND
• 4. Treatment of the patient's onychomycosis is medically necessary and not entirely for cosmetic reasons AND
• 5. Fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture, PAS staining, or PCR testing) [lab results are required] AND
• 6. If the request is for a brand agent with an available generic equivalent (e.g., Sporanox capsules vs itraconazole capsules), then ONE of the following:
• A. The patient has tried and had an inadequate response to the generic equivalent [chart notes required] OR
• B. The generic equivalent was discontinued due to lack of efficacy or adverse event [chart notes required] OR
• C. The patient has intolerance or hypersensitivity to the generic equivalent not expected to occur with the brand [chart notes required] OR
• D. The patient has an FDA labeled contraindication to the generic equivalent not expected with the brand [chart notes required] OR
• E. The generic equivalent expected ineffective or to cause adherence barrier, worsen comorbid condition, or decrease functional ability [chart notes required] OR
• F. The generic equivalent not in the patient’s best interest based on medical necessity [chart notes required] OR
• G. The patient has tried another prescription drug in the same pharmacologic class or mechanism that was discontinued due to lack of efficacy or adverse event [chart notes required] OR
• H. There is support for the use of the requested brand agent over the generic equivalent.
• B. The patient has another FDA labeled diagnosis for the requested agent and route of administration OR
• C. The patient has another indication that is supported in compendia for the requested agent and route of administration.
• AND the patient does NOT have any FDA labeled contraindications to the requested agent.

Approval duration

BCBSIL/BCBSMT: 6 months; BCBSNM: 3 months; Onychomycosis (toenail): 3 months; Onychomycosis (fingernail): 5 weeks; Solution for oropharyngeal/esophageal candidiasis: 6 weeks; All other indications: 12 months